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Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 28, 2023
Introduction into Discrete event simulation methodology (DES). Part 1. Dynamic supply & demand balance and capacity problems
Discrete event simulation (DES) is the most powerful methodology used in process data analytics. The following examples will be covered: (i) Outpatient clinic: centralized or separate locations? (ii) Outpatient clinic: non-steady-state operations, (iii) Outpa ...
- Basic & Intermediate
- 90 Mins
- Alexander Kolke
- Mar 30, 2023
Current GXP expectations on Water system validation compliance
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
- Basic & Intermediate
- 90 Mins
- Hitendra Kumar
- Mar 31, 2023
GMP overview for QC Laboratories
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Apr 03, 2023
INVENTORY PLANNING, MANAGEMENT & CONTROL
Today’s economics in business has brought many companies to address major investments like inventory with a limited results solution of outsourcing the function and/or activity. Procurement Services & Contract Manufacturing activities are typically what has ...
- Basic & Intermediate
- 75 Mins
- Michael Gozzo
- Apr 04, 2023
Biomarkers in Drug Discovery and Development
Biomarkers are a key medical product development tool capable of facilitating the development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treat ...
- Basic & Intermediate
- 60 Mins
- Stefano Persian
- Apr 05, 2023
Investigating OOS results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor, and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the step ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Apr 06, 2023
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 07, 2023
Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
- Intermediate
- 60 Mins
- Alan M Golden
- Apr 07, 2023
Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
- Intermediate
- 60 Mins
- Alan M Golden
- Apr 07, 2023